Monitoring of Symptoms and Cognitive Function Using Telehealth: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Monitoring of Symptoms and Cognitive Function Using Telehealth (NCT03184701), a na na study. The primary outcome is Patient Satisfaction.

2. Clinical Question

3. Trial Design

The registry lists this study as completed, with an enrollment of 45 participants. The study is classified as a single-group model, allocation is listed as not applicable, and masking is listed as none. Its phase is recorded as not applicable. The sponsor is Albert Einstein Healthcare Network. The recorded study start was 2016-04-30 and the primary completion date was 2018-08-30.

The intervention is described as telehealth-based remote monitoring of symptoms and cognitive function. The brief description places the intervention at the time of discharge and says it was intended to support clinical care and self-management. Participants receiving the intervention were also described as receiving routine standard of care.

There is an inconsistency in the registry wording: the arm description refers to patients randomized to the group, while the design fields classify the study as single-group and show allocation as not applicable. The registry record therefore does not establish a separate randomized control group or a controlled treatment comparison. The arm description is not enough to reinterpret the study as randomized.

Eligibility criteria, recruitment details, the protocol’s sample-size justification, and the planned statistical analysis are not reported in the registry record. The enrollment figure describes the study as registered; it does not establish how many participants contributed data to the satisfaction outcome. The number who completed the three-month survey is not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All participants who completed the end of study survey (at 3 months) are included.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: All participants are included in the study analyses.

6. Primary Endpoint

The registry lists the primary outcome as Patient Satisfaction, measured over 3 months.

The primary endpoint is the number of participants reporting satisfaction with the device. It is a participant count, with the stated assessment time at three months. The endpoint description says that participants who completed the end-of-study survey at three months are included. The registry record does not report the count of participants who said they were satisfied, the total number who completed the survey, or the survey’s specific satisfaction questions and response options.

Satisfaction is a participant-reported measure of experience with the device. It can describe whether respondents viewed the monitoring approach favorably, but it is not itself a measure of symptom change, cognitive function, medication adherence, hospitalization, or overall health outcomes. Those broader aims appear in the project description, but the registered primary outcome is satisfaction with the device.

In general, a count is easiest to interpret when its denominator is also reported: the count alone does not show what share of eligible respondents it represents. A denominator based on survey completers also describes respondents, not necessarily all enrolled participants. Because neither the observed count nor the number of completers is reported, the registry record does not permit an estimate of satisfaction or its precision.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What kind of outcome is registered?

The primary outcome is a count of participants reporting satisfaction with the device. In general, a count describes how many people met an outcome definition. For interpretation, it is useful to know both that count and the relevant denominator. In this study, the stated population is participants who completed the end-of-study survey at three months. The registry record does not report how many participants completed it or how many reported satisfaction, so neither a respondent proportion nor an uncertainty estimate can be read from the posted information.

In general, when a participant-level outcome has two possible states, an analysis may describe the number in each state and the proportion in each state, with uncertainty represented by a confidence interval. A confidence interval expresses the range of values reasonably compatible with the data and the statistical method; it does not remove limitations in the design or missing outcome information. No such estimate or interval for satisfaction is reported in the registry record.

What does a single-group design allow?

The registry classifies the study as single-group and lists allocation as not applicable. In general, a single-group study can report what was observed among participants receiving an intervention. Without a concurrent comparison group, it cannot isolate the intervention’s contribution from other influences on the outcome. A comparison with an external or historical group would require details and assumptions not reported in the registry record.

The arm description’s reference to randomization does not resolve this issue: the registered design fields do not describe a randomized comparison. The record does not report a comparator arm with outcome data, a between-group estimate, or an adjusted comparative analysis. Therefore, a comparative treatment effect cannot be interpreted from the posted results.

What statistical analyses are available?

No analysis records are listed. The registry record does not report an estimate for the primary outcome, a confidence interval, a p-value, or a statistical model. It also does not report details of a prespecified statistical analysis plan. Without those items, readers cannot assess whether the outcome was analyzed as planned, what uncertainty was attached to any estimate, or whether an inferential test was used.

In general, a p-value measures how compatible observed data are with a specified null model under the assumptions of the analysis. It does not measure the probability that a hypothesis is true, and it does not establish practical importance. A confidence interval adds information about the uncertainty and range of effect estimates. Neither type of result is available for the primary outcome in the registry record.

How should the planning illustrations be understood?

The stated planning approach describes an illustration using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It frames the effect to detect as a stated fraction of the observed effect. For time-to-event outcomes, the stated approach concerns the total number of events; for other outcomes, it concerns participants per arm. These are assumptions for planning illustrations, not evidence that the study used a two-arm design or that those assumptions formed its original protocol.

In general, a sample-size calculation depends on the chosen outcome, target effect, variability, allocation, significance level, and desired power. Planning for a smaller target effect generally requires more information than planning for a larger target effect, all else equal. Such calculations describe prospective design requirements under stated assumptions; they are not a measure of the probability that a completed study has found a true effect. The stated illustrations are not observed power.

The registry record does not report a protocol-based sample-size justification or the numerical planning outputs. Because the primary result is not reported, the illustrations cannot be read as evidence about the observed satisfaction outcome. They also do not change the single-group design classification or create a control comparison that the registry does not identify.

What assumptions would affect an outcome estimate?

In general, a valid estimate of a participant-reported outcome depends on a clear outcome definition and complete knowledge of who was assessed. If survey completion differs among participants, the responses of completers may not represent those who did not complete the survey. This is a possible source of selection bias in general; whether it occurred in this study cannot be assessed because completion numbers and missing-data details are not reported.

For a binary event outcome, statistical methods often rely on assumptions about how observations arise and how uncertainty is estimated. Over-dispersion is a general concern when variation in the data exceeds that expected under a chosen model; if unaccounted for, it can make uncertainty estimates too small. The registry record does not identify a model or provide data with which to assess over-dispersion. No model-specific conclusion is therefore possible.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Intervention Arm")
n      <- c(45)
events <- c(45)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Intervention Arm  45  45  100.0  92.1  100.0  92.1  100.0  92.3  99.9

11. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures, but it gives details for the primary satisfaction outcome only. The other outcome’s definition, assessment time, result, and analysis are not reported in the registry record. No multiplicity procedure or hierarchy for interpreting multiple outcomes is reported. In general, testing several outcomes can increase the chance of at least one apparently unusual result, so a prespecified strategy can help readers understand how multiple tests were handled. There are no reported test results to which such a procedure could be applied.

The primary outcome population is defined as all participants who completed the end-of-study survey at three months. The registry does not report the number who completed that survey, the number who did not, or reasons for noncompletion. It does not report an approach to missing responses, such as imputation, complete-case analysis beyond the population description, or sensitivity analysis. Whether missing data affected the outcome estimate therefore cannot be assessed.

The enrollment of 45 should not be assumed to equal the number included in the satisfaction analysis. The analysis population is described by survey completion, and the corresponding denominator is not reported. No participant flow or outcome-specific analysis population is listed in the registry record.

Although the project description mentions broader goals, the registry does not provide a statistical analysis plan, analysis populations beyond the primary endpoint description, or analysis records. Details of prespecified outcome selection, adjustment for multiple comparisons, and handling of missing data are not reported in the registry record.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry lists one experimental group, with 45 participants at risk for serious adverse events and 0 affected. For other adverse events, it also lists 45 at risk and 0 affected. These are counts as recorded; the registry record does not provide event descriptions or additional detail about ascertainment.

Three deaths are listed for the group. The registry record does not state their causes, timing, or relationship to the intervention. It also does not clarify how deaths relate to the adverse-event counts, so the figures should not be combined or interpreted as evidence about causation. The counts alone do not establish that the intervention caused, prevented, or had no effect on an event.

In general, safety counts are most informative when definitions, observation periods, event severity, and attribution are clear. A zero count in a group does not prove that an event is impossible or that risk is absent. Here, the listed at-risk group size and counts describe the registry’s reported figures, but the limited event detail and lack of a comparison group constrain interpretation.

13. What the Result Does, and Does Not, Mean

The registry record documents a completed project of telehealth-based remote monitoring of symptoms and cognitive function in people with end-stage liver disease. It identifies participant satisfaction with the device at three months as the primary outcome and gives an enrollment of 45. It also records serious adverse-event and other adverse-event counts for the experimental group, as well as three deaths.

Those details do not establish whether participants were satisfied: the satisfaction count and the number of survey completers are not reported. The record likewise does not report a primary-outcome estimate, interval, or test. The stated project goals, including improved self-management and reduced healthcare utilization, are intentions in the study description rather than results documented in the registry.

The design classification is single-group, and no like-for-like control group is identified in the design fields. In general, observations from one group cannot separate an intervention’s effect from other changes or influences. The arm description’s use of the word randomized does not supply the missing comparative design or outcome data.

The safety counts should also be read narrowly. The record lists zero affected participants for serious and other adverse events, alongside three deaths, but does not describe cause, timing, or attribution. These figures do not establish a causal relationship in either direction.

Overall, the registry supports a description of the study’s purpose, design classification, registered satisfaction endpoint, and limited safety counts. It does not support a conclusion about satisfaction, clinical outcomes, or comparative benefit. Absence of a reported result is not evidence that the outcome was favorable, unfavorable, or unchanged.

14. Why This Trial Matters Statistically

This study illustrates why a registered outcome definition and a reported outcome result are different things. The primary endpoint is clearly framed as a count of participants reporting satisfaction with the device among those completing the three-month survey. Without the count and denominator, readers cannot estimate the observed level of satisfaction or its precision. The enrollment figure alone cannot fill that gap because the endpoint population is survey completers.

The design classification is also central to statistical interpretation. A single-group study can provide descriptive information about participants who received an intervention, but it does not provide a concurrent control contrast. The arm text’s reference to randomization sits alongside registry fields that specify a single-group model and allocation as not applicable. Reading those elements together prevents an unsupported causal comparison.

The record also separates broad project aims from measured evidence. Improving self-management and reducing healthcare utilization are described as goals, while device satisfaction is the stated primary outcome. A goal should not be treated as a finding when outcome results are not reported. The registry lists two outcome measures, but details for the other measure are absent.

Finally, the safety counts show why raw event listings need context. The record lists zero participants affected by serious and other adverse events and three deaths, but does not report the circumstances or attribution. Statistical interpretation depends not only on counts but also on definitions, denominators, follow-up, and design. Those details determine what can responsibly be inferred from the data.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The main limitation for interpreting the primary outcome is that its result is not reported in the registry record. Neither the number reporting satisfaction nor the number completing the three-month survey is available. This prevents calculation or assessment of the observed satisfaction level and its precision. The registry does not describe the survey questions or response categories.

The design is listed as single-group, with allocation not applicable and no masking. The arm description refers to randomization, but the design fields do not establish a randomized comparison. No concurrent control group or comparative estimate is reported. Accordingly, the registry does not support attributing any observed outcome to the intervention.

The enrollment is 45, but the number contributing to each outcome is not stated. The primary endpoint includes survey completers, and the number who completed the survey is unknown. Reasons for missing surveys, missing-data methods, participant flow, and outcome-specific analysis populations are not reported in the registry record.

The registry lists two outcome measures but gives no detail on the second outcome in the available record. It also lists no analysis records and does not report a statistical analysis plan, inferential estimates, confidence intervals, p-values, or multiplicity handling. The original sample-size justification is not reported.

Safety interpretation is limited by the absence of event descriptions and information on the timing, causes, or attribution of the three deaths. The record does not clarify how deaths relate to the adverse-event counts. These limitations are specific to the information available in the registry record and do not establish what may have been reported elsewhere.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Monitoring of Symptoms and Cognitive Function Using Telehealth — NCT03184701.
• Registry record last updated 2020-04-17; status last verified 2020-04.
• Results first posted 2020-04-17.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

NCT03184701 is a completed, single-group study of telehealth-based remote monitoring of symptoms and cognitive function in people with end-stage liver disease. The registry lists enrollment of 45, no masking, allocation as not applicable, and the sponsor as Albert Einstein Healthcare Network. The recorded study start was 2016-04-30, and primary completion was 2018-08-30.

The primary outcome is the number of participants reporting satisfaction with the device at three months among end-of-study survey completers. The satisfaction count and number of completers are not reported in the registry record. No analysis records are listed. The experimental group has 45 participants listed at risk for serious and other adverse events, with 0 affected in each category; 3 deaths are listed. The registry does not report their causes or relationship to the intervention.